Die Finanzierung ist erstmal gesichert etc.
TG Therapeutics achieved positive results from the phase 2b UNITY-NHL study using umbralisib in patients with MZL.
With the positive results observed in the MZL patient population, TG Therapeutics is set to meet with the FDA soon to potentially seek accelerated approval based on the reported data.
Before any potential NDA filing for umbralisib, TG Therapeutics is going to await for additional data from MZL patients in the UNITY-NHL study such as: Safety, DOR and PFS.
TG Therapeutics recently announced $85 million in equity and debt financing that will be enough to carry the company forward, which means no risk of near-term dilution.
Looking for a portfolio of ideas like this one? Members of Biotech Analysis Central get exclusive access to our model portfolio. Start your free trial today »
TG Therapeutics (TGTX) is a good biotech to look into because it has proven itself in a few mid-stage clinical studies. The reported results from UNITY-NHL study were highly positive for the biotech and for those patients with marginal zone lymphoma (MZL). This builds upon the opportunity for the UNITY-NHL study which is exploring Umbralisib in many other non-Hodgkin's lymphoma indications. Phase 2 Data Marginal Zone Lymphoma
It was noted that TG Therapeutics saw positive results in its phase 2b UNITY-NHL study from the Marginal Zone Lymphoma cohort. Before diving any further, it is important to note that this study is testing multiple kinds of non-hodgkin's lymphoma (NHL). Therefore, this latest update on data involves only those patients with Marginal Zone Lymphoma (MZL). Specifically, this phase 2b cohort involved patients with relapsed/refractory MZL and were treated with umbralisib. In essence, umbralisib is a phosphoinositide 3-kinase (PI3K) delta inhibitor. The basic premise is that PI3K is found on both healthy cells and cancer cells. However, cancer cells have an abundant amount of PI3K that regulate them. Umbralisib has the ability to inhibit the signaling function of PI3K........................................... |